SERVICES

  • About U.S. Validation Services, LLC

    Validation Services
    With more than 30 years of industry experience, we excel in delivering pragmatic and budget-friendly solutions that guarantee the validation of your facilities, utility systems, computerized systems, software, and equipment, all while enhancing FDA compliance.
    Our seasoned team, with expertise in GMP-regulated industries, will guide you through the validation process for your facilities, utility systems, and equipment.
  • Validation Planning and Audit

    • Validation Program Auditing and Optimization
    • Policy, SOP, and Validation Master Plan Development
    • Validation Project Management
    • Protocol Development and Execution (IQ, OQ, PQ)
    • Deviation Management and CAPA Implementation
  • Risk-Based Validation Services

    • Risk Assessments and Mitigation Planning
    • Compliance and Readiness Assessments
    • Validation Master Plan (VMP) Development
    • Validation Project Management
    • GAP Analysis and Remediation Strategies
    • Development of Validation Lifecycle Documentation (Plans, Protocols, Reports, SOPs)
    • Equipment and System Qualification: FAT, SAT, IQ, OQ, PQ
  • Computerized Systems Validation

    • Software Vendor Audits
    • Validation Master Planning
    • User and Functional Requirements Specifications
    • Validation Protocol Development and Execution
  • 21 CFR Part 11 - Electronic Records & Signatures

    • Compliance Assessments
    • Gap Analysis and Remediation Planning
  • Calibration Program Management

    • Metrology Program Auditing and Optimization
    • Calibration Policies and SOP Development
    • Review and Preparation of Calibration Procedures